Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain
NCT ID: NCT01028079
Last Updated: 2009-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
338 participants
INTERVENTIONAL
2005-11-30
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 2
Ibuprofen
Ibuprofen 400 mg caplet to be given three times a day as for 2 consecutive days (48 hours), followed by ibuprofen 400 mg caplet to be given as per need, but not more than three times a day for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 1200 mg ibuprofen.
Arm 3
Placebo
Placebo (two placebos: Placebo Aspirin and Placebo Ibuprofen) to be given three times a day for a maximum of 5 consecutive days in the same regimen as for Experimental Drug and Active Comparator.
Arm 1
Acetylsalicylic Acid (Aspirin, BAYE4465)
Aspirin 1000 mg (solid dose caplet) to be given three times daily as for 2 consecutive days (48 hours), followed by Aspirin 1000 mg (solid dose caplet) to be taken as per need, but not more than three times daily for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 3000 mg Aspirin.
Interventions
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Acetylsalicylic Acid (Aspirin, BAYE4465)
Aspirin 1000 mg (solid dose caplet) to be given three times daily as for 2 consecutive days (48 hours), followed by Aspirin 1000 mg (solid dose caplet) to be taken as per need, but not more than three times daily for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 3000 mg Aspirin.
Ibuprofen
Ibuprofen 400 mg caplet to be given three times a day as for 2 consecutive days (48 hours), followed by ibuprofen 400 mg caplet to be given as per need, but not more than three times a day for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 1200 mg ibuprofen.
Placebo
Placebo (two placebos: Placebo Aspirin and Placebo Ibuprofen) to be given three times a day for a maximum of 5 consecutive days in the same regimen as for Experimental Drug and Active Comparator.
Eligibility Criteria
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Inclusion Criteria
* Body mass index ranging in-between 18 and 30 kg/m²
* Normal blood pressure
* Patients suffering from low back pain
* Low back pain, localized below the costal margin and above the inferior gluteal folds, either as acute low back pain, or as chronic or intermittent low back pain
Exclusion Criteria
* Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
* Pregnancy or lactation period
* Abuse of alcohol or addictive substances
18 Years
70 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Consumer Care Inc.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Bad Lippspringe, , Germany
Beckum, , Germany
Einbeck, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hanover, , Germany
Künzing, , Germany
Straßkirchen, , Germany
Fowey, , United Kingdom
Saltash, , United Kingdom
Sheffield, , United Kingdom
Countries
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Other Identifiers
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11818
Identifier Type: -
Identifier Source: org_study_id